A just-posted trial notification shows very early clinical trials by Allergan, for their product they have named AGN-199201. The double blind trial will compare 3 different formulations of AGN-199201 with with the vehicle. The decrease in redness will be assessed by the clinician and participant after 5 days of use.
As the trial is for the redness of rosacea, and Allergan bought Vicept Therapeutics in 2011, it is clear that AGN-199201 is the Oxymetazoline based product previously known as V-101.
Who are Allergan?
The new owners of V-101 are Allergan who are perhaps better known for making the dry eye treatment Restasis, Refresh artificial tears, and the product that was the genesis of Sansrosa – Alphagan P. Allergan are also the makers of Aczone.
What is Oxymetazoline
Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR.
A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.
Clinical Trial NCT01579084
Primary Outcome Measures: Percentage of Patients with at Least a 2-grade Decrease from Baseline on Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA)
Drug: AGN-199201 Formulation A and B
Drug: AGN-199201 Formulation B and C
Drug: AGN-199201 Formulation C and A
Drug: AGN-199201 Formulation A and AGN-199201 Vehicle
Drug: AGN-199201 Formulation B and AGN-199201 Vehicle
Drug: AGN-199201 Formulation C and AGN-199201 Vehicle
Drug: AGN-199201 Formulation A
Drug: AGN-199201 Formulation B
Drug: AGN-199201 Formulation C
Drug: AGN-199201 Vehicle